Valved conduit

ABSTRACT

Valved conduits are provided that include a leaflet construct coupled between two portions of a conduit. Each leaflet has a free edge and a leaflet attachment edge. The leaflet attachment edge is disposed between a first conduit distal end and a second conduit proximal end that are coaxial therebetween defining a junction.

FIELD

The present disclosure relates generally to prosthetic valves and morespecifically to conduits having a valve structure therein.

BACKGROUND

A number of fabrication techniques have been used to couple leaflets tothe inside of a conduit, including sewing individual leaflets to theinner surface of the conduit. In many cases, the resulting leaflet issupported on the inside surface of the conduit and defines a flap havinga mounting edge where the leaflet is coupled to the inside surface ofthe conduit and a free edge that allows the flap to move. The flap movesunder the influence of fluid pressure. In operation, the leaflets openwhen the upstream fluid pressure exceeds the downstream fluid pressureallowing flow through the conduit and closes when the downstream fluidpressure exceeds the upstream fluid pressure and blocks the flow throughthe conduit.

The process for mounting the leaflet to the inside surface of theconduit is tedious, time consuming and requires great skill. The conduitis everted to expose the inside surface of the conduit. The leaflet isprecisely cut to the correct size and shape. The attachment edge of theleaflet is sewn by hand onto the everted conduit. Additional leaflets,commonly three total, are sewn circumferentially around the evertedconduit. Once attached to the inside surface of the conduit, the conduitis reverted with the expectation that the three leaflets are properlyplaced. The three leaflets must cooperate with each other such that theymay coapt at their free edges to create a seal and prevent flow duringthe closed phase of the cardiac cycle.

Valved conduits made in this way present significant challenges. Theleaflets must be precisely cut to size and shape prior to attachment.Placement of the leaflets on the inside surface of the conduit while inan everted state and relative to the other leaflets must be held to hightolerances, usually placed by hand with without alignment tools or jigs.The punctures of the attachment edge with a needle for receiving suturenot only have to be precisely placed by hand, but the number ofpunctures must be limited to reduce structural weakening along theattachment edge. Further, all of the punctures and resulting suturepassing therethrough is exposed to the blood flow and are locatedprecisely at the line of flexure of the leaflet at the leaflet base,which can lead to reduced durability.

Leaflet durability under the repetitive loads of the leaflets openingand closing is dependent, in part, on the load distribution between theleaflet and the conduit wall. Further, substantial load is encounteredon the leaflet when in the closed position. Mechanical failure of theleaflet can arise, for example, at the mounting edge, where the flexibleleaflet is attached by the suture, particularly at the commissureregion. The repetitive loads of the leaflet opening and closing leads tomaterial failure by fatigue, creep or other mechanism, depending in parton the leaflet material. Mechanical failure at the mounting edge isespecially prevalent with synthetic leaflets.

Therefore, there remains a significant need for a valved conduit,encompassing a conduit and a valve structure, with long durability andeasier manufacture.

SUMMARY

Described embodiments are directed to apparatus, system, and methods forvalved conduits.

Embodiments of a valved conduit comprise a first conduit having a firstconduit distal end, a second conduit having a second conduit proximalend, and a valve structure including at least one leaflet. Each leaflethas a free edge and a leaflet attachment edge. The leaflet attachmentedge is disposed between the first conduit distal end and the secondconduit proximal end that are coaxial therebetween defining a junction.The leaflet attachment edge is coupled between the first conduit distalend and the second conduit proximal end.

Embodiments of a method of making a valved conduit, comprise obtaining aconduit. Cutting the conduit into a first conduit and a second conduitalong a cut line defining a first conduit distal end and a secondconduit proximal end. Defining a plurality of commissure slots in thesecond conduit proximal end. Obtaining a tube comprising one or morelayers of expanded PTFE composite. Cutting a leaflet construct includinga plurality of leaflets each being separated by a bridge region from thetube, the leaflets defining a leaflet attachment edge. Folding each ofthe bridge regions into a bridge loop and defining a coaptation neckbetween each bridge loop and two adjacent leaflets, the bridge loopsextending radially away from a tube axis. Disposing a bridge loop intoeach of the commissure slots, and suturing the first conduit distal endand the second conduit proximal end with the leaflet attachment edgetherebetween defining a junction.

Embodiments of a method of making a valved conduit, comprise obtaining aconduit, either as a tube, a flat sheet, or a flat sheet formed into atube. Cutting the conduit into a first conduit and a second conduitalong a cut line defining a first conduit distal end and a secondconduit proximal end. Defining a plurality of commissure slots in thesecond conduit proximal end. Obtaining a sheet comprising one or morelayers of expanded PTFE composite. Cutting a leaflet construct includingone or a plurality of leaflets each being separated by a bridge regionor a pair of commissure tabs from the sheet, the leaflets defining aleaflet attachment edge. Folding each of the bridge regions orcommissure tabs defining a coaptation neck between each bridge regionand two adjacent leaflets or commissure tabs, the bridge regions orcommissure tabs extending radially away from a tube axis. Disposing abridge region or commissure tabs into each of the commissure slots, andsuturing the first conduit distal end and the second conduit proximalend with the leaflet attachment edge therebetween defining a junction.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings are included to provide a furtherunderstanding of the present disclosure and are incorporated in andconstitute a part of this specification, illustrate embodimentsdescribed herein, and together with the description serve to explain theprinciples discussed in this disclosure.

FIG. 1A is a perspective, partial cut-away view of an embodiment of avalved conduit including a valve structure as disposed in the conduit;

FIG. 1B illustrates an interior downstream view of a valve structure inan open configuration;

FIG. 1C illustrates an interior downstream view of a valve structure inan closed configuration;

FIG. 2 is an exploded side view of a valved conduit with the leaflets ina closed position, in accordance with an embodiment;

FIG. 3 is a cut-away surface view of a valved conduit with the leafletsin a closed position, in accordance with the embodiment of the valvedconduit of FIG. 2;

FIG. 4 is a cut-away surface view of a valved conduit with the leafletsin an open position, in accordance with an embodiment of the valvedconduit of FIG. 2;

FIG. 5 is an exploded view wherein the annular components have been laidflat, in the case of a tube, longitudinally cut and laid open, so as tobetter illustrate the elements of the valved conduit of the embodimentof FIG. 2;

FIG. 6 is an exploded view wherein the annular components have been laidflat, in the case of a tube, longitudinally cut and laid open, so as tobetter illustrate the elements of the valved conduit of an embodimentwere the valve structure is a leaflet construct comprising a pluralityof leaflets that are joined together by a bridge region;

FIG. 7 is a side, exploded view of an embodiment of a valved conduit;

FIG. 8 is a representation of the embodiment of FIG. 7 laid flat, in thecase of a tube, longitudinally cut and laid open to a flat orientation;

FIG. 9A is a cut-away surface view of a valved conduit showing the valvestructure as a leaflet construct in a closed position, in accordancewith an embodiment;

FIG. 9B is a cut-away surface view of a valved conduit showing the valvestructure as a leaflet construct in an open position, in accordance withthe embodiment of FIG. 9A;

FIG. 10 is a close-up of the commissure showing the bridge loop of theembodiment of FIG. 9A;

FIG. 11 is a side, partially cut-away view of an embodiment of the valvestructure as a leaflet construct including a plurality of leaflets;

FIG. 12 is a close front view of the bridge region, in accordance withan embodiment;

FIG. 13A is a close-up perspective view of the bridge region inaccordance with an embodiment;

FIG. 13B is a close-up perspective view of the bridge region with aretention element in accordance with the embodiment of FIG. 13A;

FIG. 13C is a close-up side view of the bridge region with a retentionelement in accordance with the embodiment of FIG. 13A;

FIG. 14 is a side view of a valved conduit coupled using suture at thejunction, in accordance with an embodiment;

FIG. 15 is an exploded side view of an embodiment of a valved conduitincluding a support ring;

FIG. 16 is a side view of a valved conduit coupled using suture at thejunction, in accordance with another embodiment;

FIG. 17 is a cutting pattern for the conduit in a flat configuration inaccordance with an embodiment; and

FIG. 18 is a suture pattern for the embodiment of the cutting pattern ofthe embodiment of FIG. 17.

DETAILED DESCRIPTION

Persons skilled in the art will readily appreciate that various aspectsof the present disclosure can be realized by any number of methods andapparatus configured to perform the intended functions. Stateddifferently, other methods and apparatus can be incorporated herein toperform the intended functions. It should also be noted that theaccompanying figures referred to herein are not necessarily drawn toscale, but may be exaggerated to illustrate various aspects of thepresent disclosure, and in that regard, the figures should not beconstrued as limiting.

Although the embodiments herein may be described in connection withvarious principles and beliefs, the described embodiments should not bebound by theory. For example, embodiments are described herein inconnection with prosthetic valved conduits. However, embodiments withinthe scope of this disclosure can be applied toward any valved conduit,valve structure, or mechanism of similar structure and/or function.Furthermore, embodiments within the scope of this disclosure can beapplied in non-cardiac applications.

The term “leaflet”, as used herein in the context of a valved conduit,is a flexible component of a one-way valve structure wherein the leafletis operable to move between an open and closed position under theinfluence of a fluid pressure differential. In an open position, theleaflet allows blood to flow through the valve structure. In a closedposition, the leaflet substantially blocks retrograde flow through thevalve structure. In embodiments comprising multiple leaflets, eachleaflet cooperates with at least one neighboring leaflet to block theretrograde flow of blood. The pressure differential in the blood iscaused, for example, by the contraction of a ventricle or atrium of theheart, such pressure differential typically resulting from a fluidpressure building up on one surface of the leaflets when closed. As thepressure on an inflow surface of the valve structure rises above thepressure on the outflow surface of the valve structure, the leafletsopen and blood flows therethrough. As blood flows through the valvestructure into a neighboring chamber or blood vessel, the pressure onthe inflow surface of the valve structure equalizes with the pressure onthe outflow surface of the valve structure. As the pressure on theoutflow surface of the valve structure raises above the blood pressureon the inflow surface of the valve structure, the leaflet returns to theclosed position generally preventing retrograde flow of blood throughthe valve structure.

The term “valved conduit”, as used herein, is defined as a conduit witha valve structure that is within the conduit for use in coronary orvascular procedures.

The term “valve structure”, as used herein, is defined as one or moreseparate leaflets or a leaflet construct having a plurality of leafletsthat are coupled together that function as a one-way valve.

The term “leaflet construct”, as used herein, is defined as a valvedstructure comprising a plurality of leaflets that are coupled togetherwith a commissure region between each leaflet.

The term “sinus”, as used herein, is defined as a region of a conduitthat has a larger inner diameter than a surrounding region. A sinus maybe utilized to create an open volume behind and downstream from an openleaflet such that the open leaflet does not lie against the innersurface of the conduit. The sinus may direct the blood to flow betweenthe conduit inner surface and the open leaflet during forward flow toprevent blood pooling behind the leaflet, and may assist in moving theleaflet from the open position to a closed position during reversed flowconditions. The sinus may also be described as having a shape of a bulgeor concavity especially when viewed from the conduit inner surface.

The term “membrane”, as used herein, refers to a sheet comprising asingle material, such as, but not limited to, expanded fluoropolymer.

The term “composite material”, as used herein, refers to a combinationof a membrane, such as, but not limited to, expanded fluoropolymer, andan elastomer, such as, but not limited to, a fluoroelastomer. Theelastomer can be contained within a porous structure of the membrane,coated on one or both surfaces of the membrane, or a combination ofcoated on and contained within the porous structure of the membrane.

The term “laminate”, as used herein, refers to multiple layers ofmembrane, composite material, or other materials, such as elastomer, andcombinations thereof.

The term “film”, as used herein, generically refers to one or more ofthe membrane, composite material, or laminate.

The term “biocompatible material”, as used herein, generically refers toany material with biocompatible characteristics including synthetic,such as, but not limited to, a biocompatible polymer, or a biologicalmaterial, such as, but not limited to, bovine pericardium.

The term “coupled”, as used herein, means joined, connected, attached,adhered, affixed, or bonded, whether directly or indirectly, and whetherpermanently or temporarily.

Embodiments herein include various apparatus, systems, and methods for aconduit having a valve structure operable as a prosthetic valve that canbe used, such as, but not limited to, replace a pulmonary valve and aportion of the corresponding pulmonary artery. The leaflet is operableas a one-way valve wherein the conduit defines a conduit lumen intowhich the leaflets open to permit flow and close so as to occlude theconduit lumen and prevent flow in response to differential fluidpressure.

FIG. 1A is a perspective, partial cut-away view of an embodiment of avalved conduit 100 including a valve structure 120 as disposed in theconduit 200. The partial cut-away view of the valved conduit 200 shows aportion of the valved conduit 100 that is slightly downstream of thevalve structure 120, shown in a closed configuration. An upstream end502 of the valved conduit 100 may be positioned in a patient'svasculature or cardiac structure to receive blood flowing to the valvestructure 120.

FIGS. 1B and 10 illustrate an interior downstream view of a valvestructure 120 in an open configuration, and a closed configuration,respectively. In an open configuration, blood may flow through the valvestructure 120, forcing the leaflets 310 towards the conduit innersurface. In a closed configuration the leaflets 310 close toward thecenter of the conduit lumen 206 with the leaflet free edges 312 coaptingwith adjacent leaflet free edges 312 which restricts fluid backflow.

The valved conduit 100 that may be used, in a non-limiting example, as ashunt for connecting of the right ventricle to the pulmonary arteryfollowing a Norwood operation, as frequently performed for the treatmentof hypoplastic left heart syndrome. In one non-limiting example, thevalved conduit 100 may be indicated for the correction or reconstructionof the right ventricle outflow tract (RVOT) in pediatric patients. Suchreconstruction may be indicated for congenital heart disorders such astetralogy of Fallot, Truncus Arterious, Dextro-Transposition of theGreat Arteries, Pulmonary Atresia of Intact Ventricular Septum, orAortic Valvular Disease. The valved conduit 100 may also be indicatedfor the replacement of previously implanted homografts or valvedconduits that have become dysfunctional or insufficient. In addition,the valved conduit 100 may have applications in treating a wider rangeof heart disorders, including other areas of the heart.

FIGS. 2-5 show various components that are included in the valvedconduit 100, in accordance with an embodiment. FIG. 2 is an explodedside view, and FIGS. 3 and 4 are cut-away surface views, respectively,of a valved conduit 100, with the leaflets 310 in a closed and openposition, respectively, in accordance with an embodiment. The componentsof the valved conduit 100 that are visible in FIG. 2 include a valvestructure 120 including three leaflets 310 that are flexible. Theleaflet free edges 312 of the leaflets 310 come together at a coaptationregion 316 in a Y-shaped pattern (when viewed from above) to close thevalve structure 120. The valve structure 120 closes in this fashion whenthe pressure of the blood on the outflow surface is greater than thepressure of the blood on the inflow surface of the valve structure 120.The leaflet free edges 312 of the leaflets 310 move apart to open thevalve structure 120 and to let blood flow through the valve structure120 from the inflow when the pressure of the blood on the inflow surfaceof the valve structure 120 is greater than the pressure on the outflowsurface of the valve structure 120.

The leaflets 310 generally flex about the leaflet base 325 about thejunction 280 at the conduit inner surface 202 as the leaflets 310 openand close. In an embodiment, when the valve structure 120 is closed,generally about half of each leaflet free edge 312 abuts an adjacenthalf of a leaflet free edge 312 of an adjacent leaflet 310, as shown inFIG. 3. The three leaflets 310 of the embodiment of FIG. 2 meet at atriple point 318. The conduit lumen 150 is occluded when the leaflets310 are in the closed position stopping fluid flow.

In accordance with an embodiment, the conduit wall 208 is cutperpendicular to the conduit inner surface 202 at the junction 280 suchthat the leaflets 310 extend perpendicular, or 90 degrees, from theconduit inner surface 202 at the junction 280, as shown in FIG. 3. Theleaflets 310 extend from the commissure slot 217 in a directionperpendicular to the conduit inner surface 202. As such, the leaflets310 exhibit a bias toward the closed position. This is beneficial inthat the leaflets 310 will tend to close earlier during the phase of thecardiac cycle where the blood is decelerating or reversing. An earlierclosure will tend to reduce back flow through the valve structure 120.In accordance with other embodiments, at least a portion of the conduitwall 208 is cut at an angle to the conduit inner surface 202 at thejunction 280 such that at least a portion of the leaflets 310 extend ina preferred direction. In the above embodiment, the conduit wall 208 iscut at a 90 degree angle to the conduit inner surface 202 at thejunction 280. In accordance with another embodiment, the conduit wall208 is cut at an angle greater than 45 degrees to the conduit innersurface 202, extending upstream, excluding the commissure slot 217 whichremains perpendicular, such that the leaflets 310 extend at an anglegreater than 45 degrees from the conduit inner surface 202 extendingupstream at the junction 280, such that the leaflets 310 exhibit a biastoward the closed position. In accordance with another embodiment, theconduit wall 208 is cut at an angle to the conduit inner surface 202 atthe junction 280 that is between the angle of the leaflets in the openposition and the closed position such that the leaflets are in a neutralpoison, that is, biased in a position between fully open and fullyclosed. The cut angle may determine, for example, but not limited to,the opening and closing dynamics of the leaflets by imparting a bias onthe leaflets.

FIG. 5 in an exploded view wherein the annular components have been laidflat, in the case of a tube, longitudinally cut and laid open, so as tobetter illustrate the elements of the valved conduit 100. The valvedconduit 100 comprises a first conduit 210, a valve structure 120, and asecond conduit 260.

Valve Structure

The valve structure 120 comprises one or more leaflets 310. In oneembodiment, the valve structure 120 is a plurality of leaflets 310 thatare separate from each other, as shown in FIG. 5. In another embodiment,the valve structure 120 is a leaflet construct 300 comprising aplurality of leaflets 310 that are joined together by a bridge region330 between adjacent leaflets 310, as shown in FIG. 6.

Each leaflet 310 is a relatively thin sheet-like element. The materialfrom which a valve structure 120 may be fabricated may have a thicknessof about 0.02 mm to about 0.5 mm. In one embodiment, the valve structure120 may be cut out of the material by hand, or with a tool, includingpunch and die-cut tools. In another embodiment, the valve structure 120may be cut out with a laser-cutter on an automated system for accuracyand repeatability based on a pattern.

Each leaflet 310 has a leaflet free edge 312 and a leaflet attachmentedge 326. The portion of the leaflet 310 bound by the leaflet attachmentedge 326 and the leaflet free edge 312 is referred to as the leafletbelly 322. The intersection of the leaflet belly 322 and the leafletattachment edge 326 is referred to as the leaflet base 325. The leafletattachment edge 326 defines a commissure region 348 adjacent to theleaflet free edge 312. The leaflet attachment edge 326 that does notinclude the commissure region 348 defines a base attachment edge 350. Inthe embodiment of FIG. 5 showing separate leaflets 310, the commissureregion 348 defines commissure tabs 345. In the embodiment of FIG. 6, thecommissure region 348 defines the bridge region 330.

The leaflet attachment edge 326 is operable to be coupled between afirst conduit distal end 214 and a second conduit proximal end 262 thatare coaxially placed defining a junction 280, as shown in FIGS. 2, 3 and4. The leaflet base 325 is located directly adjacent the conduit innersurface 202 at the junction 280. The shape of the junction 280 at theconduit inner surface 202 defines, at least in part, the shape of theleaflet base 325. During operation of the valve structure 120, theleaflet 310 will bend at the leaflet base 325.

The leaflet attachment edge 326 of each of the leaflets 310 is extendedbetween the first conduit distal end 214 and the second conduit proximalend 262 and coupled thereto, with, such as, but not limited to, suture,adhesive, thermal bonding, or other means. In accordance with anembodiment, a portion of the leaflet attachment edge 326 extends beyondthe conduit outer surface 204.

The length CL of the commissure region 348 determines, at least in part,the length of the coaptation region 316 between adjacent leaflet freeedges 312 in embodiments of the valve structure 120 having more than oneleaflet 310. The commissure region 348 is received in and extendsthrough a commissure slot 217 defined by the second conduit proximal end262 as will be described below.

The leaflet attachment edge 326 at the commissure region 348 of adjacentleaflets 310 meet at a commissure slot 217. The height of the leaflet310 between the leaflet base 325 and the leaflet free edge 312 isoperable such that the leaflet free edge 312 of one leaflet 310 coaptswith a leaflet free edge 312 of an adjacent leaflet 310 when in theclosed position.

Referring to FIGS. 9A and 9B, as previously discussed, the shape of theleaflet base 325 is determined, at least in part, by the shape of thefirst conduit distal end 214 and the second conduit proximal end 262 atthe conduit inner surface 202 at the junction 280, referred herein asthe junction shape. The shape of the leaflet base 325 follows generallythe junction shape as it extends into the conduit lumen 206 from thejunction 280.

As shown in FIGS. 2 and 5, the first conduit distal end 214 defines aplurality of conduit parabolic valleys 242, and the second conduitproximal end 262 defines a plurality of complementary conduit parabolichills 240. The leaflet attachment edge 326 defines complementary leafletparabolic hills 140 to generally conform to the junction shape and, inan embodiment, extend from the junction 280 at the conduit outer surface204 when disposed within the junction 280, as shown in FIG. 4. Theleaflets 310 are sheet-like, relatively thin and flexible and thus takeon the shape of the second conduit parabolic hills 240 and first conduitparabolic valleys 242, and, in operation, will bend at the junction 280adjacent the conduit inner surface 202, thus defining the leaflet base325.

FIG. 7 is a side, exploded view of an embodiment of a valved conduit1100, and FIG. 8 is a representation of the embodiment of FIG. 7 laidflat, in the case of a tube, longitudinally cut and laid open to a flatorientation so as to better illustrate the elements. Each leaflet 310,at the leaflet attachment edge 326, has substantially the shape of anisosceles trapezoid having two leaflet sides 314, a leaflet base 325 anda leaflet free edge 312 opposite the leaflet base 325, corresponding tothe two leaflet attachment sides 223 and a leaflet attachment base 225defined in the first conduit distal end 214. The two leaflet sides 314diverge from the leaflet base 325, wherein the leaflet base 325 issubstantially flat.

As shown in FIG. 11, in accordance with other embodiments of the valvedconduit 100, each leaflet belly 322 includes a belly central region 329and two belly side regions 328 on opposite sides of the belly centralregion 329. The belly central region 329 is defined by a shapesubstantially that of an isosceles trapezoid defined by two bellycentral region sides 327, the leaflet base 325 and the leaflet free edge312. Each of the belly side regions 328 has a shape substantially thatof a triangle and each are defined by one of the belly central regionsides 327, one of the leaflet sides 314, and the leaflet free edge 312.

The isosceles trapezoid shape of the leaflet base 325 will produce adifferent leaflet bending character as compared with a parabolic shape.The bending characteristics of a leaflet base 325 that has a belly base324 that is flat as provided by the isosceles trapezoid shape willproduce a flat hinge-like bending at the leaflet base 325 that mayprevent bulking and wrinkling during operation as compared with arounded leaflet base 325.

As shown in FIG. 5, each of the leaflets 310 have a leaflet belly 322,and a leaflet attachment edge 326. The leaflet belly 322 of each leaflet310 is the operating portion of the leaflet 310 when in a finished andimplanted valved conduit 100. The leaflet attachment edge 326 of eachleaflet 310 is the portion that is used to secure the leaflet 310 to thejunction 280.

As previously discussed, the shape of the leaflet 310 is defined, atleast in part by the shape of the first conduit distal end 214 and theleaflet free edge 312. The shape of the leaflets 310 can also bedefined, at least in part, by the materials and processes used tomanufacture the leaflet 310, such as, but not limited, those describedbelow. For example, in accordance with an embodiment, the shape of theleaflet 310 also depends in part on molding the leaflets 310 usingmolding and trimming processes to impart a predetermined shape to theleaflet 310.

It is appreciated that the valve structure 120 with either separateleaflets or a leaflet construct 300 may be composed of any number ofleaflets 310. FIG. 2 illustrates one non-limiting example of amulti-leaflet valve structure 120 composed of three leaflets 310. It isunderstood that a valve structure 120 may be composed of any number ofleaflets 310. For example, a valve structure 120 having four leaflets310 may also be considered. In FIG. 2, a three-leaflet valve structure120 comprises three leaflets 310, each leaflet 310 having a leafletattachment edge 326 and a leaflet free edge 312. Such a three-leafletvalve structure 120 includes three commissures 346: a first commissure346 a between a first leaflet 310 a and a second leaflet 310 b, a secondcommissure 348 b between the second leaflet 310 b and a third leaflet310 c and a third commissure 346 c between the third leaflet 310 c andthe first leaflet 310 a. Each commissure 346 may have a commissurelength CL as shown in FIG. 3.

Leaflet Construct

In one embodiment, the valve structure 120 comprises a plurality ofseparate leaflets. In another embodiment, the valve structure 120comprises a leaflet construct 300 including a plurality of leaflets 310.

With reference to FIG. 6, in accordance with an embodiment, the leafletconstruct 300 defines a contiguous annular ring defining a plurality ofleaflets 310 with a commissure region 348 in the form of a bridge region330 between each of the leaflets 310, as shown in FIG. 6, and also asshown in FIG. 7 for a slightly different embodiment. As used herein,contiguous means without a break or a seam, that is, seamless. Eachbridge region 330 defines a bridge first end 332 adjacent a firstleaflet 310 a and a bridge second end 334 adjacent a second leaflet 310b. The leaflets 310 extend radially inward in the conduit lumen 206 whencoupled to the conduit 200. Each of the leaflets 310 define a leafletattachment edge 326 that is operable to extend into the junction 280between the first conduit distal end 214 and a second conduit proximalend 262.

With reference to FIG. 6, in accordance with another embodiment, theleaflet construct 300 defines a flat sheet that is subsequently formedinto an annular ring defining a plurality of leaflets 310 with acommissure region 348 in the form of a bridge region 330 between each ofthe leaflets 310, as shown in FIG. 6, and also as shown in FIG. 7 for aslightly different embodiment. In this embodiment, there will be a seamwhere the sheet is formed into a tube with the edges coupled together.Each bridge region 330 defines a bridge first end 332 adjacent a firstleaflet 310 a and a bridge second end 334 adjacent a second leaflet 310b. The leaflets 310 extend radially inward in the conduit lumen 206 whencoupled to the conduit 200. Each of the leaflets 310 define a leafletattachment edge 326 that is operable to extend into the junction 280between the first conduit distal end 214 and a second conduit proximalend 262.

FIGS. 9A and 9B are cut-away surface views of a valved conduit 100showing the valve structure 120 as a leaflet construct 300 in a closedand open position, respectively, in accordance with an embodiment. FIG.10 is a close-up of the commissure 346 showing the bridge loop 338 ofthe embodiment of FIGS. 9A and 9B. Each of the bridge regions 330 may befolded so as to define a bridge loop 338 with a coaptation neck 340between the bridge loop 338 and the adjacent leaflets 310. Thecoaptation neck 340 is operable to pass through one of the commissureslots 217 so that the bridge loop 338 is adjacent to the conduit outersurface 204 and the leaflets 310 extend radially inward from the conduitinner surface 202, as shown in FIGS. 9A and 9B when in the closedposition.

One leaflet 310 may be essentially mirror-image symmetric with respectto the commissure 346.

The leaflet construct 300 can be made of polymer. For example,pre-shaped polymer leaflets can be made by starting from a cylinder ofpolymer material and cutting into a shape like that shown in FIGS. 6, 7and 8.

The leaflet construct 300 can also be made from a flat sheet of amaterial, such as, but not limited to, a polymer material, that has beencut into a shape like that shown in FIGS. 6 and 8 and subsequentlycoupled together into an annular shape, as shown in FIG. 7. A leafletconstruct 300 having a seam, though, may not have the advantages of acontiguous, seamless construct that may exhibit a higher tensilestrength characteristics at the commissure 346. The advantages providedby a retention element 400 inside the bridge loop 338 may still berealized in embodiments where a retention element 400 is used, as willbe discussed below. It is understood that the leaflet construct 300 maybe cut from a material that is formed or has been formed into anysuitable form for the particular purpose.

Another way that the leaflet construct 300 may be formed, assuming theuse of a material for the leaflets that is suitable for formation inthis way, is by compression or injection molding.

Between each of the leaflets 310 is a bridge region 330, as shown inFIGS. 6-9. The bridge region 330 is operable to extend through thecommissure slot 217 such that a portion of the bridge region 330 extendsaway from the conduit outer surface 204. In accordance with anembodiment, the bridge region 330 is operable to be formed into a bridgeloop 338, folding about two loop fold lines 336 so as to contain aretention element 400 therein as discussed below, as shown in FIGS. 7,8, and 11. Due to the curvature of the conduit outer surface 204 as thecommissure 346, the two loop fold lines 336 form an angle alpha, whichcorresponds to retention element surfaces 402 as shown in FIG. 12, inaccordance with an embodiment.

Leaflet and Leaflet Construct Material

In accordance with an embodiment, the valve structure 120, whether theseparate leaflets 310 or the leaflet construct 300 can comprise abiocompatible material. In accordance with an embodiment, thebiocompatible material that makes up the valve structure 120 comprises abiological material, such as, but not limited to, bovine pericardium.

In accordance with an embodiment, the valve structure 120, whether theseparate leaflets 310 or the leaflet construct 300 can comprise abiocompatible material that is not of a biological source and that issufficiently compliant and strong for the particular purpose, such as abiocompatible polymer. In an embodiment, the valve structure 120comprises a membrane that is combined with an elastomer, such as byimbibing, to form a composite material.

The leaflet 310 and leaflet construct 300 can comprise, according to anembodiment, a composite material comprising an expanded fluoropolymermembrane, which comprises a plurality of spaces within a matrix offibrils, and an elastomeric material. It should be appreciated thatmultiple types of fluoropolymer membranes and multiple types ofelastomeric materials can be combined to form a composite material whileremaining within the scope of the present disclosure. It should also beappreciated that the elastomeric material can include multipleelastomers, multiple types of non-elastomeric components, such asinorganic fillers, therapeutic agents, radiopaque markers, and the likewhile remaining within the scope of the present disclosure.

In accordance with an embodiment, the composite material includes anexpanded fluoropolymer material made from porous ePTFE membrane, forinstance as generally described in U.S. Pat. No. 7,306,729 to Bacino.

The expandable fluoropolymer, used to form the expanded fluoropolymermaterial described, can comprise PTFE homopolymer. In alternativeembodiments, blends of PTFE, expandable modified PTFE and/or expandedcopolymers of PTFE can be used. Non-limiting examples of suitablefluoropolymer materials are described in, for example, U.S. Pat. No.5,708,044, to Branca, U.S. Pat. No. 6,541,589, to Baillie, U.S. Pat. No.7,531,611, to Sabol et al., U.S. patent application Ser. No. 11/906,877,to Ford, and U.S. patent application Ser. No. 12/410,050, to Xu et al.

The expanded fluoropolymer membrane can comprise any suitablemicrostructure, such as pores, for achieving the desired leafletperformance. Other biocompatible polymers which can be suitable for usein leaflet include but are not limited to the groups of urethanes,silicones (organopolysiloxanes), copolymers of silicon-urethane,styrene/isobutylene copolymers, polyisobutylene,polyethylene-co-poly(vinyl acetate), polyester copolymers, nyloncopolymers, fluorinated hydrocarbon polymers and copolymers or mixturesof each of the foregoing.

Further examples of leaflet and leaflet construct materials include:wherein the leaflet and leaflet construct comprises at least onefluoropolymer membrane layer; wherein the leaflet and leaflet constructcomprises a laminate having more than one fluoropolymer membrane layer;wherein the at least one fluoropolymer membrane layer is an expandedfluoropolymer membrane layer; wherein an elastomer is contained withinthe expanded fluoropolymer membrane layer; wherein the elastomercomprises perfluoromethyl vinyl ether and tetrafluoroethylene; whereinthe expanded fluoropolymer membrane layer comprises ePTFE; wherein theleaflet and leaflet construct comprises a composite material having atleast one fluoropolymer membrane layer having a plurality of pores andan elastomer present in the pores of at least one of the fluoropolymermembrane layers; wherein the composite material comprises fluoropolymermembrane by weight in a range of about 10% to 90%; wherein the elastomercomprises (per)fluoroalkylvinylethers (PAVE); wherein the elastomercomprises a copolymer of tetrafluoroethylene and perfluoromethyl vinylether; wherein the elastomer is silicone; wherein the elastomer is afluoroelastomer; wherein the elastomer is a urethane; and wherein theelastomer is a TFE/PMVE copolymer; wherein the TFE/PMVE copolymercomprises essentially of between about 40 and 80 weight percentperfluoromethyl vinyl ether and complementally 60 and 20 weight percenttetrafluoroethylene; and wherein the leaflet and leaflet constructcomprises silicone.

Conduit

As previously discussed, in accordance with the embodiment of FIG. 3,the valved conduit 100 includes a conduit 200 and a valve structure 120incorporated into the conduit 200. The conduit 200 is generally tubularand flexible. The conduit 200 has a conduit wall 208 defining a conduitouter surface 204 defining an outer diameter (OD) and a conduit lumen206 defining a conduit inner surface 202 having an inner diameter (ID).The wall 208 has a thickness Wd. In an embodiment, the conduit 200 hasan ID that is less than 10 mm. In another embodiment, the conduit 200has an ID that is greater than 10 mm but less than 25 mm. In yet anotherembodiment, the conduit 200 has an ID that is greater than 25 mm.

The conduit 200 comprises a first conduit 210 and a second conduit 260that are joined at a junction 280 with the valve structure 120 extendingbetween and therefrom, as will be discussed below. The first conduit 210has a first conduit proximal end 212 and a first conduit distal end 214opposite the first conduit proximal end 212. The second conduit 200 hasa second conduit proximal end 262 and a second conduit distal end 264opposite the second conduit proximal end 262. The first conduit distalend 214 has a complementary shape to the second conduit proximal end 262such that the first conduit distal end 214 may be matched up and coupledto the second conduit proximal end 262 at a junction 280.

In an embodiment, the second conduit proximal end 262 defines the shape,size and/or dimensions as the desired shape of the leaflet base 325 ofthe leaflet 310. The first conduit distal end 214 defines acomplementary shape, size and/or dimensions so as to conform to andclosely fit the shape of the second conduit proximal end 262. Thethickness of the leaflet attachment edge 326 is relatively thin and willnot obstruct the fit between the first conduit distal end 214 and thesecond conduit proximal end 262.

In accordance with an embodiment, the first conduit 210 and the secondconduit 260 are formed by cutting a length of conduit 200 into twolengths about a cut line, wherein the cut line proscribes the desiredcomplementary shape of the first conduit distal end 214 and the secondconduit proximal end 262. As will be described later, the first conduitdistal end 214 is reattached with the valve structure 120 therebetween.

Wherein the first conduit distal end 214 defines a plurality of conduitparabolic valleys 242, and wherein the second conduit proximal end 262defines a plurality of complementary conduit parabolic hills 240, asshown in FIG. 5. At the conduit hill base 244 of the conduit parabolichills 240 and between each conduit parabolic hill 240 extends acommissure slot 217. The commissure slot 217 is operable to receiveeither the commissure tabs 345 or bridge loop 338 there through. Eachcommissure slot 217 extends through the wall thickness and is alignedparallel to the axis X, the longitudinal axis of the conduit, inaccordance with an embodiment.

In one embodiment, the conduit 200 may have a wall thickness of about0.1 mm to about 1.5 mm. In another embodiment, the conduit 200 may alsohave an inner diameter of about 6 mm to about 28 mm. It is appreciatedthat a wall thickness and diameter may be smaller or larger suitable forthe particular purpose.

In accordance with an embodiment, the conduit 200 may further comprise aconduit sinus 230 in the second conduit proximal end 262 which isadjacent one or more of the leaflets 310 adjacent to the leaflet base325, as shown in FIGS. 2-4.

Conduit sinuses 230 may be generally concave with respect to the conduitinner surface 202 of the conduit 200. In one non-limiting example,conduit sinuses 230 may be generally spheroidal concave. In anothernon-limiting example, conduit sinuses 230 may be generally cubicallyconcave. It may be understood that the outline and cross section ofconduit sinuses 230 may have any geometry as long as the conduit sinuses230 maintain a concavity with respect to a conduit inner surface 202.

Again, FIG. 3 is a side view of an embodiment of the valve structure 120in a closed configuration, and FIG. 4 is a side view of an embodiment ofthe valve structure 120 in an open configuration. In the openconfiguration the leaflets 310 are disposed in an extendeddownstream-pointing position. An interior concavity of each of theconduit sinuses 230 is shown. In the closed configuration, each leaflet310 is disposed in a neutral position. In the neutral position, theleaflets 310 are disposed with respect to each other such that theirrespective leaflet free edges coapt so as to completely occlude theconduit lumen 206.

The one or more conduit sinuses 230 may be formed into the conduitaccording to any method appropriate for deforming the conduit wall 208.Examples of conduit wall 208 deformation methods may include, withoutlimitation, one or more of mechanical deformation (such as stretching ormechanical forming), heat forming, and/or vacuum forming. A conduitsinus method may deform the conduit material from the inside of aconduit via applied pressure and/or heat.

In accordance with an embodiment, the material of the conduit 200 at therigidified region 804, including the conduit sinuses 230, is densifiedand/or rigidified such that the conduit sinuses 230 and the junction 280retain their shape during handling and use. Densification refers, ingeneral, and specifically to ePTFE conduit, to a process of selectivelymaking the material more dense at selected locations, such as by heatingand pressure. For ePTFE material that may be relatively porous, thedensification process will reduce porosity and make the area more rigid.

Wherein the conduit 200 outside of the rigidified region 804 is ratherflexible, the conduit 200 at the rigidified region 804 is made to bemore rigid so as to support the circular shape of the conduit lumen 206at the junction 280 as well as better retain the shape of the sinuses575. Deformation at the junction 280 might result in the valve structure120 not operating properly. The rigidified region 804 of the conduit 200provides radial compressive strength while the conduit outer surface 204is atraumatic to adjacent tissue. The rigidified region 804 also assistsin better accuracy for cutting the parting line 802, shown in FIG. 17,as discussed below, as well as creation and placement of the firstconduit apertures 219 and second conduit apertures 269, also assistingin the use of automated manufacturing equipment.

Assembly

The first conduit distal end 214 and the second conduit proximal end 262are coupled together with the leaflet attachment edge 326 therebetweenwith any suitable process, in accordance with embodiments. Processesinvolving adhesive, heat welding, bonding, and suturing are anticipated.

In an embodiment, illustrated in FIG. 2, the valve structure 120comprise a plurality of separate leaflets 310. Each leaflet 310 isseparately affixed at the junction 280 of a conduit 200. The leafletattachment edge 326 of each leaflet 310 is disposed between the firstconduit distal end 214 and the second conduit proximal end 262 as shownin FIG. 3.

In another embodiment, illustrated in FIG. 11, the valve structure 120comprise a leaflet construct 300 including a plurality of leaflets 310.The leaflet construct 300 is affixed at the junction 280 of a conduit200 as a unit. The leaflet attachment edge 326 of each leaflet 310 isdisposed between the first conduit distal end 214 and the second conduitproximal end 262.

In accordance with an embodiment, the leaflet attachment edge 326extends from the junction 280 to adjacent the conduit outer surface 204.In accordance with another embodiment, the portion of the leafletattachment edge 326 that extends from the junction 280 to adjacent theconduit outer surface 204 is coupled to the conduit outer surface 204.

Leaflet Apertures and Suture

The first conduit distal end 214 and the second conduit proximal end 262are coupled together with the leaflet attachment edge 326 therebetweenwith suture 700, in accordance with an embodiment.

As shown in FIG. 5, in accordance with an embodiment, the leafletattachment edge 326 further comprises a leaflet aperture inner row 270of a plurality of leaflet apertures 342 collocated with the leaflet base325 and spaced apart from a leaflet aperture outer row 272 of aplurality of leaflet apertures. The distance between the leafletaperture inner row 270 and the leaflet aperture outer row 272corresponds to the thickness Wd of the conduit wall 208, as shown inFIG. 3, where the leaflet attachment edge 326 is placed therebetween atthe junction 280. The leaflet apertures 342 of the leaflet apertureinner row 270 are operable to allow passage of suture 700 therethroughadjacent the conduit inner surface 202, and the leaflet apertures 342 ofthe leaflet aperture outer row 272 are operable to allow passage ofsuture 700 therethrough adjacent the conduit outer surface 204. Theleaflet apertures 342 of the leaflet aperture inner row 270 are instaggered relationship with the leaflet apertures 342 of the leafletaperture outer row 272, so as to allow a zig-zag suture path, known inthe art as a whip stitch pattern. Also, the staggered relationshipallows for more leaflet material between adjacent leaflet apertures 342of the leaflet aperture inner row 270 and the leaflet aperture outer row272 for greater strength of the leaflet attachment edge 326.

It is understood that a number of stitch patterns may be used. Inaccordance with another embodiment, the leaflet apertures 342 of theleaflet aperture inner row 270 are in aligned relationship with theleaflet apertures 342 of the leaflet aperture outer row 272, so as toallow an in-line suture path, known in the art as a blanket stitchpattern. The in-line relationship may allow for a more efficienttightening and better retention of the alignment of the seam.

The leaflet attachment edge 326 is placed between the facing firstconduit distal end 214 and the second conduit proximal end 262 with theconduit wall 208 positioned between the leaflet aperture inner row 270and the leaflet aperture outer row 272 of the leaflet apertures 342.Suture 700 is passed from the first conduit outer surface 224 throughone of the first conduit apertures 219 to the conduit inner surface,extending along the conduit inner surface 202 then passed through anadjacent leaflet aperture 342 of the leaflet aperture inner row 270, andextending along the conduit inner surface 202 then passed through anadjacent second conduit aperture 282 to the conduit outer surface 204,extending along the conduit outer surface 204, then passed through anadjacent leaflet aperture 342 of the leaflet aperture outer row 272, andalong the conduit outer surface 204 to the next adjacent first conduitaperture 219 and so forth progressing along the respective rows ofapertures, and thus coupling the first conduit distal end 214 and thesecond conduit proximal end 262 together with the leaflet attachmentedge 326 therebetween, as shown in FIG. 14.

The first conduit 210 and the second conduit 260 are joined at thejunction 280 with the valve structure 120 extending between andtherefrom, with the leaflets 310 extending into the conduit lumen 206and the leaflet attachment edge 326 extending into the junction 280. Inaccordance with an embodiment, the leaflet attachment edge 326 extendsfrom the junction 280 to adjacent the conduit outer surface 204. Inaccordance with another embodiment, a portion of the leaflet attachmentedge 326 that extends from the junction 280 to adjacent the conduitouter surface 204 is coupled to the conduit outer surface 204.

In accordance with an embodiment, only one row of leaflet apertures 342is provided in the leaflet attachment edge 326, as shown in FIG. 7. Inaccordance with an embodiment, the one row of leaflet apertures 342 isthe leaflet aperture inner row 270 which is coupled to the junction 280with suture 700 passed along the conduit inner surface 202. Inaccordance with an embodiment, the one row of leaflet apertures 342 isthe leaflet aperture outer row 272 which is coupled to the junction 280with suture 700 passing along the conduit outer surface 204.

In accordance with embodiments, after the junction 280 is coupled, acurable sealant is applied to the junction 280 adjacent the conduitouter surface 204 which may improve coupling strength and preventleakage at the junction 280.

In any case, the leaflet 310 is not coupled to the conduit inner surface202 of the conduit 200 but extends through the conduit wall 208extending from the junction 280 into the conduit lumen 206 of theconduit 200.

Retention Element

A retention element is shown in FIGS. 8-13C. The retention element 400is an element that is operable to be disposed within the bridge loop 338formed by the bridge region 330 of the leaflet construct 300, whicheffectively prevents the bridge loop 338 from passing through thecommissure slot 217, and therefore the leaflet construct 300 ismechanically coupled to the conduit 200 at the conduit outer surface204, as shown in FIGS. 13A-13C. The retention element 400 has a widththat is larger than a width of the commissure slot 217. With theretention element 400 being disposed in the bridge loop 338, the bridgeloop 338 will be prevented from passing through the commissure slot 217,as shown in FIG. 11. The size of the bridge loop 338 should correspondclosely to the size of the retention element 400 to prevent a portion ofthe bridge region 330 from extending through the commissure slot 217 tothe conduit lumen 206 in case of the suture at the commissure slot 217loosening or failing.

In accordance with an embodiment, each bridge region 330 is wrappedaround a retention element outer surface 404 to the retention elementinner surface 402 of one of the retention elements 400 with the bridgefirst end 332 wrapped across the retention element inner surface 402 toadjacent a dividing line 416 that vertically bisects the retentionelement 400, from a first direction and the bridge second end 334wrapped across the retention element inner surface 402 to adjacent thedividing line 416 from an opposite direction, wherein the bridge firstend 332 and bridge second end 334 are adjacent to each other to define acoaptation neck 340.

In accordance with an embodiment, the retention element 400 defines arelatively flat generally rectangular shape so as to have a low profileon the conduit outer surface 204 at the commissure slot 217. Due to thecurvature of the conduit 200 at the commissure 346, the sides of theretention element 400 are formed at an angle corresponding to the twoloop fold lines 336 that form an angle alpha, as shown in FIG. 12, inaccordance with an embodiment.

In accordance with embodiments as shown in FIG. 7, the retention element400 can be flat, relatively flat, or concave on a conduit facing surfaceto correspond with the radially outer convexity of the conduit 200 atthe commissure slot 217 that the retention element 400 will be adjacentto.

The retention element 400 may be coupled to the conduit 200 at thecommissure slot 217, with, such as, but not limited to, suture,adhesive, thermal bonding, or other means.

In accordance with embodiments, the conduit 200 at the commissure slot217, the bridge region 330, and the retention elements 400 have matchingand radially aligned apertures for receiving suture 700. The bridgeregions 330 containing a retention element 400 are coupled to theconduit 200 by suturing through these matching apertures. The dashedlines in FIG. 13C show an illustrative suture pattern. The suturingwork-load is very light and not skill-demanding, especially if theapertures are created with automated equipment is accordance with apredetermined pattern. This is compared with suturing through theconduit 200 and leaflets 310 or leaflet constructs 300 without preformedapertures.

Referring to FIG. 13C, each retention element 400 has a plurality ofretention element apertures 408 that align with commissure slotapertures 209, as shown in FIG. 11, wherein the retention element 400 isplaced against the conduit outer surface 204 at the commissure slot 217with a portion of the bridge region 330 therebetween. A securementstructure, such as, but not limited to suture 700, may be used to couplethe retention element 400 to the conduit 200 at the commissure slot 217.Stitching comprising suture 700 may be passed through these alignedcommissure slot apertures 209 and retention element apertures 408 andthe bridge aperture 309 to hold each retention element 400 and thebridge region 330 to the conduit 200 at the commissure slot 217. Some orall of this suture 700 may pass through the leaflet attachment edge 326of the leaflet 310. In that event, the suture 700 will contribute tosecuring the leaflet base 325 to the conduit 200.

Examples of suitable materials for the retention elements 400 includevarious biocompatible alloys such as titanium, Elgiloy, MP35N, stainlesssteel, nitinol, etc., and various biocompatible engineering plasticssuch as acetyl polymers, and PEEK.

In accordance with another embodiment, the retention element comprises acurable material that is applied in a fluid state and cured in place inand/or around the bridge loop 338 after the bridge loop 338 is assembledto the commissure slot 217.

Support Frame

In accordance with an embodiment, a valved conduit 101 further comprisesa support frame 500 coupled to conduit outer surface 204 at the junction280. FIG. 15 is an exploded side view, and FIG. 16 is a side view of avalved conduit 101, in accordance with an embodiment. The valved conduit101 comprises a first conduit 210, a leaflet construct 300, a secondconduit 260 and the support frame 500. The support frame 500 is agenerally annular member. The support frame 500 may provide structural,load-bearing support to the junction 280, and indirectly to the leafletbase 325. The support frame 500 defines a complementary shape of thefirst conduit distal end 214, and therefore, also defines acomplementary shape of the leaflet base 325. The support frame 500 isoperable to retain a preferred shape of the junction 280, such as butlimited to, to retain a circular shape of the conduit inner surface 202at the junction 280. The support frame 500 may prevent deformation orcrushing of the junction 280 due to handling and impingement on anatomy,for example. Further, the support frame 500, if made with a radiopaquematerial, can be used as a positioning, orientation, and flow directionaid before and after placement under x-ray visualization techniques.

The support frame 500 lies on top of or just adjacent to the junction280 on the conduit outer surface 204.

In accordance with an embodiment, the support frame 500 is a formed wireinto an annular shape. In embodiments, the support frame 500 is etched,cut, laser cut, stamped, three-dimensional printed, among other suitableprocesses, into an annular structure or a sheet of material, with thesheet then formed into an annular structure.

The support frame 500 can comprise, such as, but not limited to, anyelastically deformable metallic or polymeric material that is generallybiocompatible. The support frame 500 can comprise a shape-memorymaterial, such as nitinol, a nickel-titanium alloy. Other materialssuitable for the support frame 500 include, but not limited to, othertitanium alloys, stainless steel, cobalt-nickel alloy, polypropylene,acetyl homopolymer, acetyl copolymer, other alloys or polymers, or anyother material that is generally biocompatible having adequate physicaland mechanical properties to function as a support frame 500 asdescribed herein.

The support frame 500 may be coupled to the conduit outer surfaceadjacent the junction 280 by any suitable means. In accordance with anembodiment, the suture 700 that is used to couple the first conduitdistal end 214, the valve structure 120, and the second conduit proximalend 262 is also used to capture the support frame 500 against theconduit outer surface 204 and couple it to the junction 280.

It is appreciated that other elements or means for coupling the supportframe 500 to the conduit outer surface 204 are anticipated. By way ofexample, but not limited thereto, other means, such as mechanical andadhesive means may be used to couple the support frame 500 to theconduit outer surface 204.

Valved Conduit Embodiments

In accordance with an embodiment, a valved conduit 100 comprises thefirst conduit 210, the second conduit 260, and the valve structure 120,that are coupled together at the junction 280.

In accordance with an embodiment, a valved conduit 100 comprises thefirst conduit 210, the second conduit 260, the valve structure 120, andsupport frame 500, that are coupled together at the junction 280.

In accordance with an embodiment, a valved conduit 100 comprises thefirst conduit 210, the second conduit 260, the leaflet construct 300,that are coupled together at the junction 280, and a plurality ofretention elements 400.

In accordance with an embodiment, a valved conduit 100 comprises thefirst conduit 210, the second conduit 260, the leaflet construct 300,and a support frame 500, that are coupled together at the junction 280,and a plurality of retention elements 400.

In accordance with an embodiment, leaflets 310 are attached to a conduit200 that comprises a rigidified region 804 that includes rigidifiedbulging sinuses 575 in an efficient manner. The conduit 200 is cutproximal to the sinuses 575 in the rigidified region 804, see FIG. 17,creating a junction 280, resulting in a first conduit 210 and a secondconduit 260. Wherein the conduit 200 outside of the rigidified region804 is rather flexible, the conduit 200 at the rigidified region 804 ismade to be more rigid so as to support the circular shape of the conduitlumen 206 as well as better retain the shape of the sinuses 575. Thejunction 280 in the olgive region 806 is defined by the shape of the cutline of the conduit 200. This allows the shape of the leaflet base 325to be precisely defined. The leaflet 310 extends through the junction280 of the conduit 200 to the conduit outer surface 204. Suture 700 isused to attach the leaflets 310 to the conduit 200 and the first conduit210 and the second conduit 260 to each other. This provides a strongattachment between the leaflet 310 and the conduit 200 by allowing ePTFEsuture to pass through the leaflet 310 twice, that is, on both theinside and outside of the conduit 200 as well as passing through thetotal thickness of the conduit 200. The rigidified region 804 of theconduit 200 provides radial compressive strength while the conduit outersurface 204 is atraumatic to adjacent tissue. The use of precision cutconduit and pre-located apertures for passing suture allows for ease ofmanufacturing. The valved conduit, in accordance with embodimentsherein, requires minimal components and materials, for example, but notlimited to, ePTFE conduit, leaflet material, ePTFE suture, and seamsealant.

Methods

A method of making a valved conduit, comprising providing a leafletconstruct defining a plurality of leaflets each having a free edge and aleaflet attachment edge adjacent a leaflet base, adjacent leaflets beingcoupled together by a bridge region. Forming a leaflet aperture innerrow and a leaflet aperture outer row of leaflet apertures adjacent theattachment edge, Providing a conduit and cutting the conduit along aparting line into a first conduit having a first conduit distal end anda second conduit having a second conduit proximal end, wherein theparting line proscribes a predetermined pattern suitable for a leafletbase. Providing a support frame having the shape substantially that ofthe parting line. Forming a plurality of commissure slots. Forming aplurality of apertures adjacent the first conduit distal end and thesecond conduit proximal end. Positioning the first conduit distal endand the second conduit proximal end adjacent thereto with the attachmentedge of the leaflet therebetween. Suturing along the parting line of theconduit by advancing in one of the apertures in the first conduit,through a leaflet aperture of a leaflet aperture inner row, out throughone of the apertures in the second conduit, over the outer diameter ofthe support frame, and then through a leaflet aperture of a leafletaperture outer row. Repeating the suturing with the next set ofapertures along the entire parting line. Tensioning the suture to adjointhe parting line of the first conduit distal end and the second conduitproximal end with the leaflet attachment edge disposed in the junction.

The method further comprises sealing the parting line and apertures inthe conduit.

The method further comprises forming a commissure region in the leafletattachment edge adjacent the free edge, and disposing the commissureregion of the leaflet attachment edge into commissure slots in thesecond conduit proximal end.

The method further comprises forming a loop in the commissure region ofthe leaflet, and disposing a retention element within the loop afterdisposing the commissure region into the commissure slot.

EXAMPLE

By way of example, an embodiment of a valved conduit was made asfollows:

A leaflet material was prepared having a membrane layer of ePTFE with aporous structure that was filled with a fluoroelastomer using animbibing process. More specifically, the membrane layer of ePTFE hadbeen subjected to temperatures at or above the crystalline melttemperature of PTFE and was manufactured according to the generalteachings described in U.S. Pat. No. 7,306,729. The ePTFE membrane wastested in accordance with the methods described elsewhere. The ePTFEmembrane had a mass per area of about 0.57 g/m2, a porosity of about90.4%, a thickness of about 2.5 μm, a bubble point of about 458 KPa, amatrix tensile strength of about 339 MPa in the longitudinal directionand about 257 MPa in the transverse direction. The porous structure ofthis membrane was filled with a fluoroelastomer using an imbibingprocess, where the fluoroelastomer was formulated according to thegeneral teachings described in U.S. Pat. No. 7,462,675. The copolymerused consisted essentially of between about 65 and 70 weight percentperfluoromethyl vinyl ether and complementally about 35 and 30 weightpercent tetrafluoroethylene.

The percent weight of the fluoroelastomer relative to the ePTFE wasabout 53%. The fluoroelastomer was dissolved in Novec HFE7500 (3M, StPaul, Minn., USA) in an about 2.5% concentration. The solution wascoated onto the ePTFE membrane using a mayer bar (while being supportedby a polypropylene release film) and dried in a convection oven set toabout 145° C. for about 30 seconds. After two coating steps, theresulting composite material of ePTFE/fluoroelastomer had a mass perarea of about 3.6 g/m2.

A 21 mm diameter stainless steel mandrel was obtained. The mandrel wasfitted with shrink tubing, and heated in a forced air oven set to 340 Cfor about 1 min, until the tubing conformed to the mandrel. Thirty fivelayers of the composite material possessing a width of at least 3 cm waswrapped around the shrink tubing with an elastomer rich side of thecomposite facing toward the mandrel. Another shrink tubing was fittedover the resulting wrapped mandrel. The assembly was placed in a forcedair oven set to 340 C until the shrink tubing conformed to theunderlying material. This final assembly was placed in a forced air ovenset to 280 C for approximately one hour. The final assembly was removedfrom the oven and allowed to cool. The outer shrink tubing was removed.

An ePTFE conduit having an outer diameter of 22 mm and inner diameter of20 mm was obtained. The conduit 100 was place over a 20 mm stainlesssteel mandrel, and compressed axially to approximately 55% of itsoriginal length, and heat treated with a CO₂ laser to form a center highePTFE density section that extended approximately 20 mm in length.

Three sinuses were formed in the conduit in the high ePTFE densitysection at the same axial location but configured approximately 120°apart using the following technique. A three-piece blow mold was cut ina metal cylindrical tube whose inner diameter was the same as the outerdiameter of the conduit. The mold was sectioned into 120° segments, witheach segment including a milled hole whose perimeter defined theperimeter of the desired sinus. These segments were assembled andstandard hose clamps tightened on each end of the mold. An oversizeePTFE balloon (outer diameter approximately 30 mm) was built using aknown technique. The conduit was then inserted within the mold,centering its densified section over the holes in the mold. The balloonwas inserted into the conduit, and pressurized to approximately 4 atm.The holes in the mold were then heated using a hot air gun having a setpoint of 850° F. for about 1 minute each. During this time, the conduitdistended into the holes creating the sinuses. After forced air cooling,the balloon was deflated and the mold disassembled by loosening eachpipe clamp at the ends of the mold.

On the inflow side of the sinus, the tube was cut in a pattern definingthe attachment path of the leaflets, including the commissure slots 217as shown in FIG. 17. This cutting was performed using a CO₂ laser, oralternatively could be performed using a sharp blade. Additionally,first conduit apertures 219 and second conduit apertures 269 were cut oneither side of this parting line 802 to define a suturing path, as shownin FIG. 18.

The first conduit 210 and the second conduit 260 were placed over theends of two 20 mm mandrels and positioned with complementary portions,that is, the first conduit distal end 214 and the second conduitproximal end 262, adjacent to one another.

The leaflet pattern as shown in FIG. 6, including the leaflet apertures342, was cut into the leaflet material using a CO₂ laser, in a patternto correspond to the parting line and apertures for the suturing path inthe conduit, as shown in FIG. 18. The leaflet apertures in the leaflethad offset apertures for the suture corresponding to both the conduitinner surface and the conduit outer surface of the conduit 200. Theseleaflet apertures distribute the load bearing stress to both the conduitinner surface 202 and the conduit outer surface 204 of the conduit.

A support frame was made from Nitinol wire which was wound and shape setusing conventional techniques. The two ends of the wire frame werecoupled using welding. The frame had a shape matching the parting line802 of the conduit 200.

The conduit sections (first conduit and second conduit), leaflets, andsupport frame were assembled by using a suture (e.g., GORE-TEX SutureCV-6). Three sutures were used, one per each leaflet attachment. Thefirst conduit distal end and the second conduit proximal end werepositioned approximately 2 cm apart, and the suturing was started usinga pattern progressing along the parting line 802 of the conduit 200 asshown in FIG. 18. The suturing pattern advanced by going in one of theapertures in the first conduit, through a leaflet aperture of a leafletaperture inner row in the leaflet, out through one of the apertures inthe second conduit, over the outer diameter of the support frame, andthen through a leaflet aperture of a leaflet aperture outer row in theleaflet. This pattern is repeated with the next set of holes along theentire junction.

After completing suturing of the pattern, the suture was progressivelytensioned around its circumference to adjoin the parting line (junction)of the first conduit distal end and the second conduit proximal end withthe leaflets sandwiched in the middle of the junction. This sewingpattern resulted in functioning leaflets.

The parting line (junction) and apertures in the conduit were sealed byusing a room temperature vulcanizing silicone applied thereto andallowed to dry for greater than 24 hours. The leaflets 310 were observedto be biased in the closed position.

1. A valved conduit comprising: a conduit including a first conduithaving a first conduit distal end and a second conduit having a secondconduit proximal end, the conduit has a conduit inner surface and aconduit outer surface the first conduit distal end defining a pluralityof commissure slots; and a valve structure including at least oneleaflet, each leaflet having a free edge and a leaflet attachment edge,the leaflet attachment edge disposed between the first conduit distalend and the second conduit proximal end that are coaxial therebetweendefining a junction, wherein the leaflet attachment edge is coupledbetween the first conduit distal end and the second conduit proximalend.
 2. The valved conduit of claim 1, wherein the first conduit distalend and the second conduit proximal have a complementary shape.
 3. Thevalved conduit of claim 1, wherein in the first conduit distal enddefines a plurality of parabolic valleys, and wherein the second conduitproximal defines a plurality of complementary conduit parabolic hills.4. The valved conduit of claim 3, wherein the conduit parabolic hillsfurther define commissure slots extending axially therefrom andtherebetween, wherein a portion of the leaflet attachment edge that isadjacent to the free edge extends through the commissure slots.
 5. Thevalved conduit of claim 4, wherein the valve structure is a leafletconstruct comprising a plurality of separate leaflets, each leafletincluding a commissure region that defines commissure tabs, wherein eachof the commissure tabs are operable to be received within one of thecommissure slots.
 6. The valved conduit of claim 1, wherein the valvestructure is a leaflet construct comprising a plurality of leaflets thatare joined together by a bridge region between adjacent leaflets.
 7. Thevalved conduit of claim 1, wherein the valve structure comprises aleaflet construct defining a contiguous annular ring comprising aplurality of leaflets and a bridge region between each of the leaflets,the leaflets extend radially inward from the first conduit distal end,each of the leaflets defining an attachment region, a portion of theattachment region being between the first conduit distal end and thesecond conduit proximal end, each of the bridge regions extendingthrough one of the commissure slots and defining a bridge loop that isadjacent to a conduit outer surface.
 8. The valved conduit of claim 7,further comprising a retention element having a width that is largerthan a width of the commissure slot, the bridge region defining a brideloop, the retention element being disposed in the bridge loop andoperable to prevent the bridge loop from passing through the commissureslot.
 9. The valved conduit of claim 7, wherein an elastomer is disposedwithin the bridge loop and cured making the bridge loop have a dimensionlarger than a dimension of the commissure slot so as to prevent thebridge loop from passing through the commissure slot.
 10. The valvedconduit of claim 1, wherein at least a portion of the leaflets extend atan angle greater than 45 degrees from the conduit inner surface in adownstream direction at the junction, whereby the leaflets exhibit abias toward a closed position.
 11. The valved conduit of claim 1,wherein the leaflets extend perpendicular from the conduit inner surfaceat the junction, whereby the leaflets exhibit a bias toward a closedposition.
 12. The valved conduit of claim 1, wherein the leaflets extendat an angle to the conduit inner surface in a downstream direction atthe junction that is between the angle of the leaflets in an openposition and a closed position.
 13. The valved conduit of claim 1,wherein the first conduit distal end, the leaflet attachment edge, andthe second conduit proximal end are coupled together with suture. 14.The valved conduit of claim 13, wherein the first conduit distal endcomprises a plurality of first conduit apertures, and wherein the secondconduit proximal end comprises a plurality of second conduit apertures,wherein the leaflet attachment edge further comprises a leaflet apertureinner row including a plurality of leaflet apertures, wherein theleaflet attachment edge is disposed within the junction such that theleaflet aperture inner row is adjacent the conduit inner surface,wherein the suture passes through the leaflet apertures and extendsalong a conduit inner surface coupling the first conduit distal end, theleaflet attachment edge, and the second conduit proximal end together.15. The valved conduit of claim 13, wherein the first conduit distal endcomprises a plurality of first conduit apertures, and wherein the secondconduit proximal end comprises a plurality of second conduit apertures,wherein the leaflet attachment edge further comprises a leaflet apertureouter row including a plurality of leaflet apertures, wherein theleaflet attachment edge is disposed within the junction such that theleaflet aperture outer row is adjacent a conduit outer surface, whereinthe suture passes through the leaflet apertures and extends along theconduit outer surface coupling the first conduit distal end, the leafletattachment edge, and the second conduit proximal end together.
 16. Thevalved conduit of claim 13, wherein the first conduit distal endcomprises a plurality of first conduit apertures, and wherein the secondconduit proximal end comprises a plurality of second conduit apertures,wherein the leaflet attachment edge further comprises a leaflet apertureinner row including a plurality of leaflet apertures and a leafletaperture outer row including a plurality of leaflet apertures, whereinthe leaflet attachment edge is disposed within the junction such thatthe leaflet aperture inner row is adjacent a conduit inner surface, andthe leaflet aperture outer row is adjacent a conduit outer surface,wherein suture passes through the leaflet apertures and extends alongthe conduit inner surface and the conduit outer surface coupling thefirst conduit distal end, the leaflet attachment edge, and the secondconduit proximal end together.
 17. The valved conduit of claim 13,wherein the first conduit distal end comprises a plurality of firstconduit apertures, and wherein the second conduit proximal end comprisesa plurality of second conduit apertures, wherein the leaflet attachmentedge further comprises a leaflet aperture inner row of a plurality ofleaflet apertures collocated with a leaflet base and spaced apart from aleaflet aperture outer row of a plurality of leaflet apertures, adistance between the leaflet aperture inner row and the leaflet apertureouter row corresponds to a thickness of a conduit wall, where theleaflet attachment edge is located therebetween at the junction, theleaflet apertures of the leaflet aperture inner row are operable toallow passage of the suture therethrough adjacent a conduit innersurface, and the leaflet apertures of the leaflet aperture outer row areoperable to allow passage of the suture therethrough adjacent a conduitouter surface, the leaflet apertures of the leaflet aperture inner rowbeing in staggered relationship with the leaflet apertures of theleaflet aperture outer row so as to allow a zig-zag suture path.
 18. Thevalved conduit of claim 13, wherein the first conduit distal endcomprises a plurality of first conduit apertures, and wherein the secondconduit proximal end comprises a plurality of second conduit apertures,wherein the leaflet attachment edge further comprises a leaflet apertureinner row of a plurality of leaflet apertures collocated with a leafletbase and spaced apart from a leaflet aperture outer row of a pluralityof leaflet apertures, wherein the leaflet attachment edge is disposedbetween the first conduit distal end and the second conduit proximal endwith a conduit wall positioned between the leaflet aperture inner rowand the leaflet aperture outer row of the leaflet apertures, wherein thesuture is passed from a first conduit outer surface through one of thefirst conduit apertures to the conduit inner surface, extending along aconduit inner surface then passed through an adjacent leaflet apertureof the leaflet aperture inner row, and extending along the conduit innersurface then passed through an adjacent second conduit aperture to theconduit outer surface, extending along the conduit outer surface, thenpassed through an adjacent leaflet aperture of the leaflet apertureouter row, and along the conduit outer surface to a next adjacent firstconduit aperture and so forth progressing along respective rows ofapertures, and thus coupling the first conduit distal end and the secondconduit proximal end together with the leaflet attachment edgetherebetween.
 19. The valved conduit of claim 1, wherein the leafletattachment edge is coupled to a conduit outer surface at the junction.20. The valved conduit of claim 1, wherein the leaflet attachment edgeof each of the leaflets extends between the first conduit distal end andthe second conduit proximal end and coupled thereto with means selectedfrom a list consisting of suture, adhesive, and thermal bonding.
 21. Thevalved conduit of claim 1, wherein the second conduit further comprisesa plurality of sinuses adjacent the second conduit proximal end, andwherein each leaflet is adjacent one of the sinuses.
 22. The valvedconduit of claim 21, wherein the sinuses are generally concave withrespect to a conduit inner surface of the conduit.
 23. The valvedconduit of claim 22, wherein the junction including the sinuses are moredense and/or more rigid than a rest of the second conduit such that thesinuses retain their shape during handling and use.
 24. The valvedconduit of claim 1, further comprising a support frame coupled to aconduit outer surface at the junction, the support frame being agenerally annular shape.
 25. The valved conduit of claim 24, wherein thesupport frame defines a complementary shape of the first conduit distalend, and also defines a complementary shape of a leaflet base.
 26. Thevalved conduit of claim 24, wherein the support frame is operable toretain a circular shape of the conduit inner surface at the junction.27. The valved conduit of claim 24, wherein the support frame is made ofa radiopaque material and operable to be seen under x-ray visualizationtechniques.
 28. The valved conduit of claim 24, wherein the supportframe lies on top of or just adjacent to the junction on the conduitouter surface.
 29. The valved conduit of claim 24, wherein the supportframe is coupled to the conduit outer surface adjacent the junction by asuture that couples the first conduit distal end, the valve structure,and the second conduit proximal end.
 30. The valved conduit of claim 1,wherein the leaflet comprises at least one fluoropolymer membrane layer.31. The valved conduit of claim 1, wherein the leaflet comprises alaminate having more than one fluoropolymer membrane layers.
 32. Thevalved conduit of claim 31, wherein the at least one fluoropolymermembrane layer is an expanded fluoropolymer membrane layer.
 33. Thevalved conduit of claim 32, wherein an elastomer is contained within aporous structure of the expanded fluoropolymer membrane layer, coated onone or both surfaces of the expanded fluoropolymer membrane layer, or acombination of coated on and contained within the expanded fluoropolymermembrane layer.
 34. The valved conduit of claim 33, wherein theelastomer comprises perfluoromethyl vinyl ether and tetrafluoroethylene.35. The valved conduit of claim 33, wherein the expanded fluoropolymermembrane layer comprises ePTFE.
 36. The valved conduit of claim 1,wherein the leaflet comprises a composite material having at least onefluoropolymer membrane layer having a plurality of pores and anelastomer present in the pores of at least one of the fluoropolymermembrane layers.
 37. The valved conduit of claim 36, wherein thecomposite material comprises fluoropolymer membrane by weight in a rangeof about 10% to 90%.
 38. The valved conduit of claim 36, wherein theelastomer comprises (per)fluoroalkylvinylethers (PAVE).
 39. The valvedconduit of claim 36, wherein the elastomer comprises a copolymer oftetrafluoroethylene and perfluoromethyl vinyl ether.
 40. The valvedconduit of claim 36, wherein the fluoropolymer membrane layer comprisesePTFE.
 41. The valved conduit of claim 36, wherein the elastomer issilicone.
 42. The valved conduit of claim 36, wherein the elastomer is afluoroelastomer.
 43. The valved conduit of claim 36, wherein theelastomer is a urethane.
 44. The valved conduit of claim 36, wherein theelastomer is a TFE/PMVE copolymer.
 45. The valved conduit of claim 44,wherein the TFE/PMVE copolymer comprises essentially of between about 40and 80 weight percent perfluoromethyl vinyl ether and complementally 60and 20 weight percent tetrafluoroethylene.
 46. A valved conduitcomprising: a leaflet; and a conduit, wherein the leaflet includes aportion that is external to the conduit and a portion that is internalto the conduit.
 47. The valved conduit of claim 46, wherein the leafletextends perpendicular from a conduit inner surface such that the leafletis biased towards a closed position.
 48. The valved conduit of claim 46,wherein the leaflet extends from a conduit inner surface at an angle ofgreater than 45 degrees such that the leaflet is biased towards a closedposition.
 49. The valved conduit of claim 46, wherein the conduitincludes sinuses that are distal from the leaflets.
 50. A valvedconduit, comprising: a conduit including a first conduit having a firstconduit distal end and a second conduit having a second conduit proximalend defining commissure slots, the conduit having a conduit innersurface and a conduit outer surface; and a leaflet construct definingone or more leaflets and a bridge region, wherein each of the bridgeregions pass through one of the commissure slots, and wherein theleaflets extend from the conduit inner surface.
 51. The valved conduitof claim 50, wherein the leaflet construct is a contiguous annular ringdefining a plurality of leaflets and a bridge region between each of theleaflets, each bridge region defining a bridge loop and a coaptationneck, and wherein each of the coaptation necks passes through one of thecommissure slots with the bridge loop being adjacent the conduit outersurface and wherein the leaflets extend from the conduit inner surface.52. The valved conduit of claim 51, further comprising a plurality ofretention elements, each retention element being operable to be receivedwithin the bridge loop, each retention element having a dimension largerthan a width of the commissure slot, wherein one of the retentionelements is received within each bridge loop with the bridge loop beingadjacent to the conduit outer surface.
 53. The valved conduit of claim50, wherein the leaflets extend from the commissure slot in a directionperpendicular to the conduit inner surface.
 54. The valved conduit ofclaim 50, wherein the leaflet construct is mechanically coupled to theconduit at the conduit outer surface.
 55. A method of making a valvedconduit, comprising: obtaining a conduit: cutting the conduit into afirst conduit and a second conduit along a cut line defining a firstconduit distal end and a second conduit proximal end; defining aplurality of commissure slots in the second conduit proximal end;obtaining a material comprising one or more layers of expanded PTFEcomposite; cutting a leaflet construct including a plurality of leafletseach being separated by a bridge region from the material, the leafletsdefining an leaflet attachment edge; folding each of the bridge regionsdefining a bridge loop and a coaptation neck, the coaptation neckextending radially from a conduit inner surface; disposing respectivecoaptation necks into each of the commissure slots; and suturing thefirst conduit distal end and the second conduit proximal end with theleaflet attachment edge therebetween defining a junction.
 56. The methodof claim 55, further comprising: providing a support frame; and couplingthe support frame about the junction adjacent a conduit outer surface.57. The method of claim 55, further comprising: obtaining a plurality ofretention elements; and disposing a retention element into each of thebridge loops adjacent an outer surface of the conduit.
 58. The method ofclaim 55, further comprising sealing the parting line and apertures inthe conduit.
 59. A method of making a valved conduit, comprising:providing a leaflet construct defining a plurality of leaflets eachhaving a free edge and a leaflet attachment edge adjacent a leafletbase, adjacent leaflets being coupled together by a bridge region;providing a conduit; cutting the conduit along a parting line into afirst conduit having a first conduit distal end and a second conduithaving a second conduit proximal end, wherein the parting lineproscribes a predetermined pattern suitable for a leaflet base, theconduit having a conduit inner surface and a conduit outer surface;forming a plurality of commissure slots at second conduit proximal end;forming a commissure region in the leaflet attachment edge adjacent thefree edge, and disposing the commissure region of the leaflet attachmentedge into the commissure slots in the second conduit proximal end; andcoupling the first conduit distal end and the second conduit proximalend adjacent therewith with the leaflet attachment edge of the leaflettherebetween defining a junction.
 60. The method of claim 59, furthercomprising: providing a support frame having a shape substantially thatof the parting line; and coupling the support frame to an outer surfaceat a junction.
 61. The method of claim 60, further comprising: forming aplurality of apertures adjacent the first conduit distal end and thesecond conduit proximal end; forming a leaflet aperture inner row and aleaflet aperture outer row of leaflet apertures adjacent the leafletattachment edge; suturing along the parting line of the conduit byadvancing suture in one of the apertures in the first conduit distal endto the conduit inner surface, passing through a leaflet aperture of aleaflet aperture inner row, passing out through one of the apertures inthe second conduit proximal end to the conduit outer surface, over anouter diameter of the support frame, and then through a leaflet apertureof a leaflet aperture outer row; repeating the suturing with a next setof apertures along the parting line; and tension the suture to adjointhe parting line of the first conduit distal end and the second conduitproximal end with the leaflet attachment edge disposed in the junction.62. The method of claim 59, further comprising: forming a loop in thebridge region of the leaflet construct; and disposing a retentionelement within the loop after disposing the bridge region into thecommissure slot.
 63. The method of claim 59, further comprising: forminga plurality of apertures adjacent the first conduit distal end and thesecond conduit proximal end; forming a leaflet aperture inner row and aleaflet aperture outer row of leaflet apertures adjacent the leafletattachment edge; suturing along the parting line of the conduit byadvancing suture in one of the apertures in the first conduit distal endto the conduit inner surface, passing through a leaflet aperture of aleaflet aperture inner row, passing out through one of the apertures inthe second conduit proximal end to the conduit outer surface, and thenthrough a leaflet aperture of a leaflet aperture outer row; repeatingthe suturing with a next set of apertures along the parting line; andtension the suture to adjoin the parting line of the first conduitdistal end and the second conduit proximal end with the leafletattachment edge disposed in the junction.
 64. The method of claim 59,further comprising sealing the parting line and apertures in theconduit.
 65. The valved conduit of claim 1, wherein the first conduitdistal end defines a first conduit joint surface and the second conduitproximal end defines a second conduit joint surface at the junction thatis complementary with the first conduit joint surface, the first conduitjoint surface and the second conduit joint surface are substantiallyplanar and adapted to interface closely together to produce a tight seamwhen coupled together, the first conduit joint surface and the secondconduit joint surface are at an angle greater than 45 degree to theconduit inner surface in a downstream direction such that at least aportion of the leaflets extend at an angle greater than 45 degrees fromthe conduit inner surface in the downstream direction at the junction,whereby the leaflets exhibit a bias toward a closed position.
 66. Thevalved conduit of claim 1, wherein the first conduit distal end definesa first conduit joint surface and the second conduit proximal enddefines a second conduit joint surface at the junction that iscomplementary with the first conduit joint surface, the first conduitjoint surface and the second conduit joint surface are substantiallyplanar and adapted to interface closely together to produce a tight seamwhen coupled together, the first conduit joint surface and the secondconduit joint surface are perpendicular to the conduit inner surfacewherein the leaflets extend perpendicular from the conduit inner surfaceat the junction, whereby the leaflets exhibit a bias toward a closedposition.
 67. The valved conduit of claim 1, wherein the first conduitdistal end defines a first conduit joint surface and the second conduitproximal end defines a second conduit joint surface at the junction thatis complementary with the first conduit joint surface, the first conduitjoint surface and the second conduit joint surface are substantiallyplanar and adapted to interface closely together to produce a tight seamwhen coupled together, the first conduit joint surface and the secondconduit joint surface are at an angle to the conduit inner surface in adownstream direction at the junction that is at or between an angle ofthe leaflets in an open position and a closed position wherein theleaflets extend at an angle to the conduit inner surface in thedownstream direction at the junction that is at or between the angle ofthe leaflets in the open position and the closed positions.